FEATURE ARTICLES

It’s been a little over a year since Sanat Chattopadhyay was named president of Merck Manufacturing Division (MMD), and this month he gives an exclusive interview on the status of the division’s transformational turnaround.

ALSO IN THIS MONTH'S ISSUE

“You don’t have time to invest in basic research and wait 10 years. You have to go find individuals and companies doing exciting research, engage them, and progress those new technologies through collaborations and funding,” explains Takeda’s Vincent Ling.

While some pharma companies struggle to backfill their pipelines, others find the opposite, that they have more development opportunities than they can pursue. While this may seem to be a nice problem to have, it also means that otherwise good drug candidates may be pushed down the list of priorities.

According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.

As the biotech sector in the U.S. continues to grow, it is doing so not just in hubs, but in smaller places like New Hampshire — where some of the state’s biopharma entrepreneurs say: “Smaller is better.”

WEB-EXCLUSIVE EDITORIAL

Both regulators and sponsors bear responsibility for saying what they mean, and interpreting correctly what’s being said. However, in a dynamic interaction, with so much riding on the outcome, this is not always simple. A solution to a potential impasse in these situations is to adopt a more nuanced approach based on a benefit-risk framework and discussion.

The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent.1,2 The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

The Infectious Disease Research Institute (IDRI) is poised to embark on a bold new step — it plans to take its early-stage candidates and deploy them in larger, later-stage human clinical trials in a wider range of settings, with the express purpose of having an expanded portfolio of vaccines, adjuvants, and therapeutics to fight the diseases of the poor.

There is a lack of awareness about pharmaceutical medical information (MI) services. Approximately 40 percent of health care practitioners are unaware that dedicated MI departments exist and can provide quality information.

We recently reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future. First up is Mark W. Ginestro, principal in KPMG's Healthcare and Life Sciences strategy team.

BEYOND THE PRINTED PAGE

In the upcoming September issue of Life Science Leader, we will feature an article on how Allergan’s Chairman, President, and CEO, Brent Saunders, conceived and created Allergan’s now-famous social contract. You’ll likely be stunned at the approach that was taken and how quickly it was executed.

To prepare you for that article, we’ve obtained Allergan’s permission to publish the social contract here in its entirety. Remember, though, only paid subscribers will be able to access the September issue’s article on Saunders and Allergan, so if you are not yet a subscriber to Life Science Leader magazine, go here to subscribe at a special rate .

While it is a little early in the Merck Manufacturing Division (MMD) transformation to determine what, if anything, he would have done differently, it is likely Sanat Chattopadhyay will explore this exercise in the near future. “Every time I complete an assignment, whether a transformation or consolidation, I reflect on what was done and realize that there are always some missteps,” shares Chattopadhyay, the president of MMD. “For example, when I was in India, I did the transformation from internal to external manufacturing too fast. Sometime I could benefit from right-sizing my own ambition,” he says with a smile.

In July I had two interesting opportunities. The first was on July 12, 2017 when I attended the Partnering For Cures (Twitter hashtag #FCP4C) conference in Boston. The second took place on July 19, when I got to tour GSK’s vaccine manufacturing facility in Marietta, PA. And while you might not think that a biopharmaceutical conference and a manufacturing facility would have much in common, in actuality they do, as both are focused on delivering safe and effective, high-quality medicines to patients as quickly and efficient as possible. Here are some highlights from my recent experiences.